活性制药成分和药物产品中的杂质:批判性审查
Cleydson Finotti Cordeiro1, Lucas Lopardi Franco1, Diogo Teixeira Carvalho1
1Faculty of Pharmaceutical Sciences, Federal University of Alfenas (UNIFAL-MG), Alfenas, Minas Gerais, Brazil.
Critical reviews in analytical chemistry
|July 26, 2024
概括
控制制药杂质对于患者安全至关重要. 本综述审查了全球法规和先进的分析方法,用于检测和管理药物副产品,确保更安全的药物.
科学领域:
- 制药科学 制药科学
- 药品安全 药品安全
- 监管事务 监管事务
背景情况:
- 活性药物成分 (API) 和药物产品中的杂质对健康构成重大风险,包括潜在的副作用和致变性.
- 确定制药副产品的可接受限度对于最小化与药物治疗相关的风险至关重要.
研究的目的:
- 批判性地审查药品杂质的关键方面,包括立法,指导方针和分析技术.
- 评估与药物杂质相关的毒理和变异原体风险.
主要方法:
- 评估主要立法和监管机构的指导方针,如FDA,EMA,ICH和药典.
- 在Scopus,ScienceDirect,PubMed和Web of Science等数据库中对最近的文章 (2013-2023) 的文献搜索.
- 讨论污染物量化和毒理/致变性风险评估的分析技术.
主要成果:
- 目前的立法 (ICH Q3A/B/D/C/E,M7/M3,Q6A,FDA,EMA指南) 提供了一个强大的杂质控制框架.
- 尽管存在框架,但全球不同地区仍然缺乏协调和标准化程序.
- 分析技术的进步提高了检测杂质和降解产品的灵敏度和选择性.
结论:
- 制药行业和卫生机构表现出强烈的承诺,以确保药物的安全性和有效性.
- 分析方法的不断改进和监管方法的协调对于有效的杂质管理至关重要.
- 解决污染物控制标准的区域差异对于全球患者安全是必要的.
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